Seasonal Allergic Rhinitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-11-01FDA Approved: ASTEPRO ALLERGY — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for AStepro Allergy (azelastine HCl) from Bayer HealthCare LLC, resulting in updated labeling for th…
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FDA approval · 2021-10-15FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under an approved ANDA. This action …
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FDA approval · 2021-06-17FDA Approved: ASTEPRO ALLERGY — Original Application (Bayer HealthCare LLC.)
FDA approved ASTEPRO ALLERGY (azelastine hydrochloride) under Bayer HealthCare LLC.'s original NDA, establishing its intranasal antihistamin…
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FDA approval · 2021-04-16FDA Approved: DYMISTA — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for DYMISTA (azelastine hydrochloride and fluticasone propionate) submitted by Viatris Specialty LLC…
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FDA approval · 2021-02-18FDA Approved: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE — Original Application (Padagis Israel Pharmaceuticals Ltd)
The FDA approved Padagis Israel Pharmaceuticals' azelastine hydrochloride and fluticasone propionate nasal spray as an original ANDA, provid…
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FDA approval · 2021-01-25FDA Approved: OLOPATADINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's supplemental application for olopatadine hydrochloride (ANDA209420), authorizing changes unde…
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FDA approval · 2020-11-24FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's supplemental application for montelukast sodium. This action grants regulatory approval for c…
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FDA approval · 2020-10-20FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, marking approval of a generic montelukast product und…
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FDA approval · 2020-10-08FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application to allow Lannett Company, Inc. to market a generic Montelukast Sodium product (ANDA 200405).
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FDA approval · 2020-10-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved Torrent Pharmaceuticals Limited's supplemental application for montelukast sodium, authorizing the regulatory action for th…
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FDA approval · 2020-09-04FDA Approved: MONTELUKAST SODIUM — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' Montelukast Sodium as a generic version of montelukast for the prevention and maintenance treatment of …
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FDA approval · 2020-08-14FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc. This action authorizes changes to the p…
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FDA approval · 2020-02-24FDA Approved: ALLERGY RELIEF — Original Application (Publix Super Markets Inc)
FDA approved Publix Super Markets Inc's original application for a generic fexofenadine hydrochloride allergy relief product (brand name All…
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FDA approval · 2019-11-08FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approved Ajanta Pharma USA Inc.'s supplemental application for montelukast sodium.
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FDA approval · 2019-11-08FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, enabling the generic montelukast product (ANDA 20…
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FDA approval · 2019-11-08FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)
FDA approves Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, updating regulatory status for the product.
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FDA approval · 2019-11-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental ANDA for montelukast sodium from Rising Pharma Holdings, enabling the marketing of a generic montelukast sodium …
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FDA approval · 2019-10-18FDA Approved: ALLERGY RELIEF — Original Application (WALMART INC. (see also Equate))
The FDA approved Walmart's original application for an over-the-counter allergy relief product containing fexofenadine hydrochloride (Allerg…
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FDA approval · 2019-08-09FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast) by Organon LLC, marking an additional regulatory action for the product.
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FDA approval · 2019-08-09FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC.
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FDA approval · 2018-12-21FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast) submitted by Organon LLC.
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FDA approval · 2018-11-21FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application to add Claritin Chewable Grape and Bubblegum (loratadine) as a new chewable dosage form, expanding t…
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FDA approval · 2018-07-31FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approves Torrent Pharmaceuticals Limited's original ANDA for montelukast sodium (generic montelukast).
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FDA approval · 2018-05-18FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for montelukast submitted by BluePoint Laboratories under ANDA 203366. The decision denotes appr…
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FDA approval · 2018-04-18FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application to add Claritin Liqui-Gels (loratadine) as a new dosage form in the Claritin product line, manufactu…